510(k) · Cleared
ClearedModel Pdexa Bone Densitometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norland Corp. · KGI Densitometer, Bone
Cleared on Feb 1, 1995 after a 649-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 1, 1995
- Review
- 649 days
- Class
- Class II
- Product code
- KGI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK931996 Model Pdexa Bone DensitometerNorland Corp. · 1995
- Descendant · cites it directly · 1 of its ownK980125 Reference Population for Norland Apollo X-Ray Bone DensitometerNorland Corp. · 1998
- Descendant · cites it directly · 0 of its ownK993176 Multi-Racial Reference Population for Pdexa and DiscoveryNorland Medical Systems, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK993337 Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK972882 ApolloNorland Corp. · 1997
- Descendant · cites it directly · 0 of its ownK972053 Pixi Young Adult Referenc Population for OS Calcis and ForearmLunar Corp. · 1997
Most influential descendants
Showing 5 of 5 · See all- K980125Reference Population for Norland Apollo X-Ray Bone DensitometerNorland Corp. · 1998 · cites it directly1descendant
- K993176Multi-Racial Reference Population for Pdexa and DiscoveryNorland Medical Systems, Inc. · 2000 · cites it directly0descendants
- K993337Apollo Multi-Racial Reference PopulationNorland Medical Systems, Inc. · 2000 · 2 generations on0descendants
- K972882ApolloNorland Corp. · 1997 · cites it directly0descendants
- K972053Pixi Young Adult Referenc Population for OS Calcis and ForearmLunar Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931996 | Model Pdexa Bone Densitometer | Norland Corp. | 1995 | — |
| +1 | K980125 | Reference Population for Norland Apollo X-Ray Bone Densitometer | Norland Corp. | 1998 | — |
| +1 | K993176 | Multi-Racial Reference Population for Pdexa and Discovery | Norland Medical Systems, Inc. | 2000 | — |
| +2 | K993337 | Apollo Multi-Racial Reference Population | Norland Medical Systems, Inc. | 2000 | — |
| +1 | K972882 | Apollo | Norland Corp. | 1997 | — |
| +1 | K972053 | Pixi Young Adult Referenc Population for OS Calcis and Forearm | Lunar Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGI device
- #1 K252718 Lunar Astrascore 13.3 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980125 (Norland Corp., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KGI devicesKGI Densitometer, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGI
156in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGI
8in 2025
MAUDE reports naming product code KGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 5 | 173 | 6 | 2 |
| 2009 | 1 | — | 9 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 5 |
| 2012 | 5 | 142 | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 3 | 156 | 0 | 8 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K931996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931996: Model Pdexa Bone Densitometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931996
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026